In early April FDA launched a new performance management system that will assess more than 300 activities in its 100-plus offices, dubbed FDA-Track. Managers will report specific actions, which are posted every month for public viewing. For example, in January FDA received 52,101 adverse event reports, approved two REMS and granted approval to two first generics. Activities are tracked and analyzed through FDA-Track dashboards; CDER has dashboards for 10 offices, though data has not yet been compiled for several of those. FDA-Track is part of FDA's transparency initiative, its implementation of the Obama Administration's directive to agencies to be more transparent (1"The Pink Sheet" DAILY, April 7, 2010)
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
